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1、·制劑技術(shù)·中目茄2014年9月5日第23卷第l7期PreparationTechnologyChinaPharmaceuticalsVo1.23,No.17,September5,2014環(huán)維黃楊星D雙層片的制備方法及體外評(píng)價(jià)許宣林,鄧亞利(1.陜西中醫(yī)學(xué)院制藥廠,陜西成陽712083;2.華南農(nóng)業(yè)大學(xué)制藥工程系,廣東廣州510642)摘要:目的研究環(huán)維黃楊星D雙層片的處方,并進(jìn)行體外評(píng)價(jià)(體外釋放度)。方法通過單因素考察法分別確定雙層片的速釋層和緩釋層處方組成與制備方法。采用紫外分光光度法測(cè)定雙層片的體外釋放度。結(jié)果環(huán)維黃楊星D雙層片中,速釋層處方組成為淀粉、羧
2、甲基淀粉鈉、硬脂酸鎂,工藝采用濕法制粒;緩釋層處方組成為卡波姆、硬脂酸鎂,采用干粉末直接壓片。體外釋放度結(jié)果表明,速釋層在5rain累積釋放度達(dá)95%以上,緩釋層能在14h內(nèi)維持恒定的釋藥量,滿足零級(jí)釋放方程。結(jié)論環(huán)維黃楊星D雙層片的處方合理,制備工藝簡(jiǎn)單,可達(dá)到速釋和緩釋的雙重作用。關(guān)鍵詞:環(huán)維黃楊星D;雙層片;體外釋放度中圖分類號(hào):TQ461;R284.1文獻(xiàn)標(biāo)識(shí)碼:A文章編號(hào):1006—4931(2014)17—0056—03PreparationandinVitroEvaluation0fCVB—DDoubleLayerTabletsXuXuanlin,De
3、ngYali。rJ.PharmaceuticalFactory,ShaanxiUniversityofTraditionalChineseMedicine,Xianyang,Shaanxi,China712083;2.DepartmentofPharmaceuticalEngineering,SouthChinaAgricultureUniversity,Guangzhou,Guaagdong,China510642)Abstract:ObjectiveToprepareCyclovirobuxine—D(CVB—D)DoubleLayerTabletsandtoc
4、onducttheinvitroevaluation(invitrore—lease1.MethodsTheformulacompositionandthepreparationtechnologyofthefastreleaselayerandtheslowreleaselayerofCVB—DDoubleLayerTabletsweredeterminedbythesinglefactortests.ThedrugreleaseinvitrowasdeterminedbytheUVspectrophotom—etry.ResutsInCVB—DDoubleLay
5、erTablets.thefastreleaselayerwascomposedofstarch,sodiumcarboxymethylstarch(CMS—Na)andmagnesiumstearate,andpreparedbythewetgranulationmethod.Theslowreleaselayerwascomposedofstarch,carbomerandmag—nesiumstearate,andpreparedbythedrygranulationmethod.Theinvitroreleaseresultsshowedthatthecum
6、ulativereleaseofthefastreleaselayerwasabove95%in5minandtheslowreleaselayercouldmaintainingtheconstantdrugreleasingamountwithin14h,whichmetthezero—orderreleaseequation.ConclusionTheformulaofCVB—DDoubleLayerTabletsisrational,thepreparationtech—nologyissimple,andthedoubleroleoffastrelease
7、andslowreleaseisachieved.Keywords:CVB—D:doublelayertablet;releaseinvitro環(huán)維黃楊星D是從黃楊科植物小葉黃楊及其同屬植物中提增強(qiáng)心肌收縮力、改善心臟泵功能以及對(duì)一定的心肌保護(hù)作用。取的一種生物堿,商品名為黃楊寧,亦稱環(huán)常綠黃楊堿D、黃楊堿在治療冠心病、心絞痛。。。的藥物中,以環(huán)維黃楊星D制成的單等,化學(xué)結(jié)構(gòu)屬孕甾烷的衍生物,分子式為CHN0,為我國(guó)研昧藥制劑黃楊寧因其標(biāo)本兼治、不良反應(yīng)小的特點(diǎn)備受關(guān)注。國(guó)制成功的治療心腦血管疾病的新藥。該藥具有降低心肌耗氧量、內(nèi)的環(huán)維黃楊星D以普通劑型為主,如